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FDA gives Elekta green light for its Esprit Leksell Gamma Knife system

by John R. Fischer, Senior Reporter | October 31, 2022
Alzheimers/Neurology Rad Oncology Operating Room
Esprit Leksell Gamma Knife system (Photo courtesy of Elekta)
The FDA has cleared Elekta’s newest Leksell Gamma Knife radiosurgery platform, Elekta Esprit.

Among other indications, the system can treat multiple metastases, arteriovenous malformations, trigeminal neuralgia and vestibular schwannoma. It is designed to automate and speed up treatment planning, and to personalize the radiosurgery experience.

Elekta unveiled it in May at the European Society for Radiotherapy and Oncology (ESTRO) 2022.

It received CE marking in August, and will now be available in the U.S. and other countries where FDA approval is recognized.

“Thanks to the very low dose delivered outside the target, it's able to protect surrounding healthy tissue. Esprit takes Gamma Knife to the next level with improvements in both the patient and user experience,” said Verena Schiller, president of Elekta's neuroscience solutions, in a statement.

The Leksell Gamma Knife consists of a single robotic system with three collimators that automatically adjust their size based on treatment plan protocols. It provides fast, painless treatment, often in outpatient surgical settings, and saves patients the hassle of being put under general anesthesia or even convalescence.

Esprit is built with an accuracy of <0.3 mm, and treatment planning can be completed in less than 60 seconds. It has flexible workflow options for single session, fractionated, adaptive or staged protocols. It is this accuracy, combined with the low body dose, that spares health tissue from damage.

The solution offers clinicians frameless or frame-based workflows that come with stronger visualization capabilities. It also has remote accessibility and collaboration tools that clinicians can use to adjust treatment to changes in their environments.

Over 90,000 patients receive Gamma Knife surgery annually for nearly 60 intracranial conditions, with long-term published data showing positive patient outcomes and improved quality of life, according to Elekta. There also is evidence that the solution can be used for a wide range of neurosurgical and oncological brain indications.

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